Comparison of Total Daily Doses of 16 Active Components in Three Dosage Forms of Fuzi Lizhongwan

Zhi-qian SONG; Chun WANG; Jia-he GAN; Zhang-chi NING; Xin-ling MA; Dong-rui LIANG; Xiao-ying WAN; Zhen-li LIU

doi:10.13422/j.cnki.syfjx.20190849

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Comparison of Total Daily Doses of 16 Active Components in Three Dosage Forms of Fuzi Lizhongwan

Classic Prescriptions | 更新时间：2021-02-09

- Comparison of Total Daily Doses of 16 Active Components in Three Dosage Forms of Fuzi Lizhongwan
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 25, Issue 19, Pages: 17-24(2019)
- 作者机构：
  
  中国中医科学院　中医基础理论研究所，北京　 100700
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20190849
  CLC： R22; R28; R94; O657.7; C37
- Received：30 October 2018，
  
  Published Online：04 January 2019，
  
  Published：05 October 2019
- 稿件说明：
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Zhi-qian SONG, Chun WANG, Jia-he GAN, et al. Comparison of Total Daily Doses of 16 Active Components in Three Dosage Forms of Fuzi Lizhongwan[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(19): 17-24.
DOI：

Zhi-qian SONG, Chun WANG, Jia-he GAN, et al. Comparison of Total Daily Doses of 16 Active Components in Three Dosage Forms of Fuzi Lizhongwan[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(19): 17-24. DOI： 10.13422/j.cnki.syfjx.20190849.

摘要

目的：

对比服用附子理中丸大蜜丸、浓缩丸和片剂后16个活性成分的总量。

方法：

按文献所载工艺制备附子理中丸大蜜丸、片剂和浓缩丸。采用RRLC-QqQ-MS分析16个活性成分的含量，色谱条件为Accucore RP-MS色谱柱(2.1 mm×100 mm，2.6 μm)，流动相0.1%甲酸水溶液(A)-0.1%甲酸乙腈溶液(B)梯度洗脱(0～3 min，15%～55%B；3～9 min，55%B；9～12 min，55%～80%B；12～12.01 min，80%～100%B；12.01～13 min，100%B)，流速0.3 mL·min

－1

，柱温30 ℃；质谱条件为电喷雾离子源，正、负离子切换模式检测，多反应监测模式(MRM)扫描。由于不同剂型中16个成分含量差异悬殊，因此通过归一化法处理，以综合评分比较每日服用3种剂型后16个活性成分的总量差异。

结果：

3种剂型制备工艺中制附子均为原粉入药，因此6个生物碱成分含量无显著差异；大蜜丸中干姜、党参、炒白术和炙甘草也为原粉入药，而浓缩丸和片剂经过提取、浓缩等热处理过程，因此10个相应成分在大蜜丸中含量显著高于浓缩丸和片剂(

0.01)；浓缩丸和片剂比较，干姜和白术渗漉时乙醇体积分数不同、党参和甘草提取溶剂种类不同等，显示10个成分也存在显著差异。当综合考虑制备工艺、处方和服用量时，则日服用大蜜丸、浓缩丸和片剂16个成分的总量分别为18.764，17.530，5.676 mg，归一化处理后的综合评分分别为0.605 4，0.717 5和0.312 4，说明浓缩丸评分最高。

结论：

由于制备工艺、处方和服用量的不同，附子理中丸大蜜丸、浓缩丸和片剂日服用量中16个活性成分的总量明显不同。

Abstract

Objective:

To compare the total daily doses of 16 active components in big honeyed pills

concentrated pills and tablets of Fuzi Lizhongwan.

Method:

Three dosage forms of Fuzi Lizhongwan were prepared according to the process described in the literature. RRLC-QqQ-MS was employed to analyze the contents of 16 active ingredients with mobile phase of 0.1%formic acid aqueous solution-0.1%formic acid acetonitrile solution for gradient elution

the separation was performed on a Accucore RP-MS column(2.1 mm×100 mm

2.6 μm) with a flow rate of 0.3 mL·min

-1

and the column temperature at 30 ℃

the mass spectrometry condition was electrospray ion source

positive and negative ion switching mode for detection

multi-reaction monitoring mode(MRM) for scanning. The contents of 16 active ingredients were calculated

and the normalization arithmetic method was used for comparing the total daily doses of these active ingredients in three dosage forms of Fuzi Lizhongwan.

Result:

Processed products of Aconiti Lateralis Radix Praeparata were used as raw powder in preparation process of the three dosage forms

so there was no significant difference in the contents of six alkaloids in the three dosage forms

while the contents of other 10 active ingredients from Zingiberis Rhizoma

Codonopsis Radix

Atractylodis Macrocephalae Rhizoma and Glycyrrhizae Radix et Rhizoma Praeparata cum Melle were significantly higher in big honeyed pills than those in concentrated pills or tablets(

0.01)

due to the differences in the extracting solvents(ethanol and water) and ethanol concentration

the contents of other 10 active ingredients between concentrated pills and tablets were also significant differences. The total daily doses of these 16 active components were 18.764

17.530

5.676 mg in big honeyed pills

concentrated pills and tablets

respectively. The concentrated pills exhibited the highest normalization arithmetic score of 0.717 5 compared with 0.605 4 and 0.312 4 separately in big honeyed pills and tablets

it was mainly owing to the maximum amount of raw material per day in concentrated pills.

Conclusion:

The total daily doses of 16 active ingredients in the three dosage forms of Fuzi Lizhongwan are significantly different caused by preparation process

prescription and dosage.

关键词

Keywords

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